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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K871512
Device Name SL-100 ND:YAG LASER FOR GYNECOLOGY USE
Applicant
Medical Energy, Inc.
2413 Executive Plz.
Pensacola,  FL  32504
Applicant Contact DAVID P LEWING
Correspondent
Medical Energy, Inc.
2413 Executive Plz.
Pensacola,  FL  32504
Correspondent Contact DAVID P LEWING
Regulation Number878.4810
Classification Product Code
GEX  
Date Received04/20/1987
Decision Date 07/08/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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